Assessment of Physical Functioning and Handling of Spiolto Respimat in Patients With COPD (OTIVACTO)

N/ATerminatedNCT02720757

Boehringer Ingelheim132 enrolled

Overview

The primary objective of this Non Interventional Study is to measure changes in physical functioning, a surrogate for physical activity and exercise capacity, in COPD patients on treatment with Spiolto® Respimat® in routine daily treatment after approximately 6 weeks. A secondary objective is to evaluate the patient's general condition (physician's evaluation) from Visit 1 (baseline visit at the start of the study) to Visit 2 (final visit at the end of the study, approx. 6 weeks after Visit 1), as well as patient satisfaction with Spiolto® Respimat® at Visit 2.

Study Type

OBSERVATIONAL

Enrollment

132

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Spiolto RespimatDRUG

Tiotropium bromide + Olodaterol

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Written informed consent prior to participation 2. Female and male patients = 40 years of age 3. Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto® Respimat® SmPC and COPD GOLD guideline recommendation Exclusion criteria: 1. Patients with contraindications according to Spiolto® Respimat® SmPC 2. Patients who have been treated with a Long-acting beta2 adrenoceptor agonist\\Long-acting muscarinic antagonist (LABA/LAMA) combination (free and fixed dose) in the previous 6 weeks. 3. Patients continuing Long-acting beta2 adrenoceptor agonist Inhalative Corticosteroids (LABA-iCS) treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists 4. Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks 5. Pregnancy and lactation 6. Patients currently listed for lung transplantation 7. Current participation in any clinical trial or any other non-interventional study of a drug or device Further exclusion criteria apply

Outcomes

Primary Outcomes

Percentage of Patients With Therapeutic Success After Approximately (Approx.) 6 Weeks After Baseline

"Therapeutic success" is defined as a 10-point increase of physical functioning (PF)-10 between Visit 1 (baseline) and Visit 2 (approx. 6 weeks later) using a PF questionnaire, which is a subdomain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with "yes, limited a lot", "yes, limited a little", or "No, not limited at all", with a score of 1, 2, or 3. The scores over the 10 questions will be summed, resulting in a value between 10 (a patient answering all questions with "yes, limited a lot") and 30 (a patient answering all questions with "No, not limited at all"). The final sum of the individual scores will be standardized to a range of 0 to 100 using the following formula: 100\*(sum-10)/20. Percentage of patients with therapeutic success after approximately 6 weeks after baseline are presented

Time frame: Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)

Secondary Outcomes

Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 (Approx. 6 Weeks Later)

Change in PF-10 score was determined by taking into account the individual change of each patient between Visit 1 and Visit 2. PF questionnaire, is a sub-domain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with "yes, limited a lot", "yes, limited a little", or "No, not limited at all", with a score of 1, 2, or 3. The scores over the 10 questions will be summed, resulting in a value between 10 (a patient answering all questions with "yes, limited a lot") and 30 (a patient answering all questions with "No, not limited at all"). The final sum of the individual scores will be standardized to a range of 0 to 100 using the following formula: 100\*(sum-10)/20.

Time frame: Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)

General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later)

The treating physician used the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8(excellent). PGE will be completed before and approx. 6 weeks after treatment initiation. Count of patients with PGE score 2, 3, 4, 5, 6, 7, 8 are presented for Visit 1 and Visit 2.

Time frame: Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)

Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction

A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. Count of patients with divisions from very dissatisfied to very satisfied are presented.

Time frame: Visit 2 (approx. 6 weeks post baseline)

Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device

Time frame: Visit 2 (approx. 6 weeks post baseline)

Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device

Time frame: Visit 2 (approx. 6 weeks post baseline)

Assessment of Physical Functioning and Handling of Spiolto Respimat in Patients With COPD (OTIVACTO)

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Secondary Outcomes